Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue
ConditionLiver Transplant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJaekeun Kim
About this trial
The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults >/= 18 years old
Recipient of LDLT
Disqualifiers
Patients who are deemed unsafe for participation for any reason by our multi-disciplinary liver transplant selection committee.
Patients < 18 years old
Patients who cannot provide informed consent
Patients receiving deceased donor liver transplants, or who are not undergoing Liver transplant (LT)
Trial design
Design model
Single group
Treatments tested in this trial
MiMedx AmnioFix
Biological/VaccineMiMedx Amniofix to be placed on biliary anastomosis of the recipient during living donor liver transplant.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Living Donor Liver Transplant (LDLT) graft recipientOther 1 intervention
Trial outcomes
Primary outcomes
1
Biliary complications
Biliary complications will be defined as any confirmed leakage of bile into the peritoneal cavity outside of the ductal system or biliary stricture.
Time frame
1 year post living donor liver transplantSecondary outcomes
1
Post-operative Complication Rates
Rates of postoperative complications and outcomes including: Re-operation, acute or chronic graft rejection, procedural intervention (in total and biliary in nature), delayed graft function, primary graft non-function, surgical site infection
Time frame
1 year post living donor liver transplant2
Post-operative Hospital Length of Stay
Hospital length of stay
Time frame
From date of transplant until date of discharge from hospital, assessed up to 365 days3
Post-operative ICU Length of Stay
ICU length of stay (days)
Time frame
From date of transplant until date of transfer out of ICU, assessed up to 365 days4
Readmissions
Number of readmissions post-operatively
Time frame
1 year post living donor liver transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jaekeun Kim
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov